- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03979326
Biomechanical Changes During Menstrual Cycle
December 1, 2020 updated by: Piotr Michalik, Medical University of Silesia
Biomechanical Changes in Young Women During Menstrual Cycle
The aim of the work is to assess the effect of the menstrual cycle on the biomechanical properties of the muscles.
The study will be conducted among young women aged 20-25 with a regular menstrual cycle.
During the test, muscle strength and muscle flexibility as well as activation times will be performed.
The study will assess the effect of the stretching of the hamstring muscles on the biomechanical properties of the muscles in the different phases of the menstrual cycle.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Śląskie
-
Katowice, Śląskie, Poland, 40-752
- Recruiting
- Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 26 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Regular menstrual cycle lasting 28 days (+/- 5 days)
- A menstrual cycle that has been present for at least 2 years
- No hormonal contraception
- Lack of pain in the lower spine
- No restriction of mobility in the hip joint
Exclusion Criteria:
- Irregular menstrual cycle
- BMI value below 18.5 and above 25
- Orthopedic disorders in the lower limb
- Neurological disorders
- Normal flexibility of the hamstring muscles
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Young women during various of phases of menstrual cycle.
The group of 40 young women will have their hamstring muscle stretched in different phases of the menstrual cycle: follicular, ovulatory and luteal.
Static stretching will last 3x 45 seconds with a 15 second break between repetitions.
Before and after the intervention a series of tests will be performed.
|
Static stretching lasting 3 x 45 seconds will be performed in each of the examined women three times in different phases of the menstrual cycle: follicular, ovulatory and luteal.
Before and after the intervention, a series of tests assessing the influence of stretching on biomechanical parameters will be carried out
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during follicular phase of menstrual cycle
|
Hamstring flexibility will be assessed using AKE and PKE and SLR tests.
|
Change measured before and immediately after static stretching during follicular phase of menstrual cycle
|
|
Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
|
Hamstring flexibility will be assessed using AKE and PKE and SLR tests.
|
Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
|
|
Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during luteal phase of menstrual cycle
|
Hamstring flexibility will be assessed using AKE and PKE and SLR tests.
|
Change measured before and immediately after static stretching during luteal phase of menstrual cycle
|
|
Passive Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during follicular phase of menstrual cycle
|
Hamstring flexibility will be assessed using PKE test
|
Change measured before and immediately after static stretching during follicular phase of menstrual cycle
|
|
Passive Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
|
Hamstring flexibility will be assessed using PKE test
|
Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
|
|
Passive Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during luteal phase of menstrual cycle
|
Hamstring flexibility will be assessed using PKE test
|
Change measured before and immediately after static stretching during luteal phase of menstrual cycle
|
|
Active Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during follicular phase of menstrual cycle
|
Hamstring flexibility will be assessed using SLR tests.
|
Change measured before and immediately after static stretching during follicular phase of menstrual cycle
|
|
Active Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
|
Hamstring flexibility will be assessed using SLR tests.
|
Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
|
|
Active Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during luteal phase of menstrual cycle
|
Hamstring flexibility will be assessed using SLR tests.
|
Change measured before and immediately after static stretching during luteal phase of menstrual cycle
|
|
Hamstring passive stifness
Time Frame: Change measured before and immediately after static stretching during follicular phase of menstrual cycle
|
Hamstring stiffness will be assessed using TDK test.
During the test the resistance of the elongated Hamstring muscle is measured.
If the resistance value is smaller after the intervention it means that muscle stiffness changed.
|
Change measured before and immediately after static stretching during follicular phase of menstrual cycle
|
|
Hamstring passive stifness
Time Frame: Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
|
Hamstring stiffness will be assessed using TDK test.
During the test the resistance of the elongated Hamstring muscle is measured.
If the resistance value is smaller after the intervention it means that muscle stiffness changed.
|
Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
|
|
Hamstring passive stifness
Time Frame: Change measured before and immediately after static stretching during luteal phase of menstrual cycle
|
Hamstring stiffness will be assessed using TDK test.
During the test the resistance of the elongated Hamstring muscle is measured.
If the resistance value is smaller after the intervention it means that muscle stiffness changed.
|
Change measured before and immediately after static stretching during luteal phase of menstrual cycle
|
|
Trunk acivity is assessed using Stabilizer Pressure Biofeedback
Time Frame: Three repetitions with a 30-second break between. The measure is taken during follicular phase of menstrual cycle
|
The torso activation scheme is measured during lower and upper limb motions using Chattanooga Stabilizer Pressure Biofeedback.
|
Three repetitions with a 30-second break between. The measure is taken during follicular phase of menstrual cycle
|
|
Trunk acivity is assessed using Stabilizer Pressure Biofeedback
Time Frame: Three repetitions with a 30-second break between. The measure is taken during ovulation phase of menstrual cycle
|
The torso activation scheme is measured during lower and upper limb motions using Chattanooga Stabilizer Pressure Biofeedback.
|
Three repetitions with a 30-second break between. The measure is taken during ovulation phase of menstrual cycle
|
|
Trunk acivity is assessed using Stabilizer Pressure Biofeedback
Time Frame: Three repetitions with a 30-second break between. The measure is taken during luteal phase of menstrual cycle
|
The torso activation scheme is measured during lower and upper limb motions using Chattanooga Stabilizer Pressure Biofeedback.
|
Three repetitions with a 30-second break between. The measure is taken during luteal phase of menstrual cycle
|
|
Hamstring strength is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Change measured before and immediately after static stretching. The measure is taken during follicular phase of menstrual cycle
|
Muscle strength of hamstring is tested.
Three repetitions of muscle strength testing are performed with two 30-second intervals.
The participants are asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
|
Change measured before and immediately after static stretching. The measure is taken during follicular phase of menstrual cycle
|
|
Hamstring strength is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Change measured before and immediately after static stretching. The measure is taken during ovulation phase of menstrual cycle
|
Muscle strength of hamstring is tested.
Three repetitions of muscle strength testing are performed with two 30-second intervals.
The participants are asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
|
Change measured before and immediately after static stretching. The measure is taken during ovulation phase of menstrual cycle
|
|
Hamstring strength is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Change measured before and immediately after static stretching. The measure is taken during luteal phase of menstrual cycle
|
Muscle strength of hamstring is tested.
Three repetitions of muscle strength testing are performed with two 30-second intervals.
The participants are asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
|
Change measured before and immediately after static stretching. The measure is taken during luteal phase of menstrual cycle
|
|
Strength of arm flexors and extensors and hip flexors is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during follicular phase of menstrual cycle
|
Muscle strength of arm flexors and extensors and hip flexors is tested.
Three repetitions of muscle strength testing are performed with two 30-second intervals.
The participants are asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
|
Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during follicular phase of menstrual cycle
|
|
Strength of arm flexors and extensors and hip flexors is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during ovulation phase of menstrual cycle
|
Muscle strength of arm flexors and extensors and hip flexors is tested.
Three repetitions of muscle strength testing are performed with two 30-second intervals.
The participants are asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
|
Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during ovulation phase of menstrual cycle
|
|
Strength of arm flexors and extensors and hip flexors is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during luteal phase of menstrual cycle
|
Muscle strength of arm flexors and extensors and hip flexors is tested.
Three repetitions of muscle strength testing are performed with two 30-second intervals.
The participants are asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
|
Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during luteal phase of menstrual cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Magdalena Dąbrowska-Galas, Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Anticipated)
May 1, 2021
Study Completion (Anticipated)
November 1, 2021
Study Registration Dates
First Submitted
February 13, 2019
First Submitted That Met QC Criteria
June 6, 2019
First Posted (Actual)
June 7, 2019
Study Record Updates
Last Update Posted (Actual)
December 2, 2020
Last Update Submitted That Met QC Criteria
December 1, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- stretching w cyklu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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